Compositions for treatment and methods for making and using the same

ABSTRACT

A detergent composition, a method of making the detergent composition, and a method of use thereof are provided. The detergent composition comprises at least 0.001% by weight of an antimicrobial agent, based on the total weight of the composition; an enzyme; and at least 0.01% by weight of a hydrotrope, based on the total weight of the composition.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/691,224 filed Jun. 28, 2018, which is incorporated herein byreference.

FIELD

The present disclosure relates to compositions for treatment and methodsof making and using those compositions.

BACKGROUND

Various medical devices are employed for procedures in the medicalfield. One such device is an endoscope that examines the interior of ahollow organ or cavity of the body. Ensuring reusable medical devicesare treated property can inhibit or prevent cross-contamination and thespread of disease. In this regard, treatment solutions such as, forexample, cleaning solutions and/or antimicrobial solutions are used onmedical devices and facility surfaces.

SUMMARY

In one aspect, the present disclosure provides a detergent composition.The detergent composition comprises at least 0.001% by weight of anantimicrobial agent, based on the total weight of the composition, anenzyme, and at least 0.01% by weight of a hydrotrope, based on the totalweight of the composition.

In another aspect, the present disclosure provides a method of making adetergent composition. The method comprises combining, based on thetotal weight of the composition, at least 0.001% by weight of anantimicrobial agent, at least 0.01% by weight of a hydrotrope, and anenzyme.

In yet another aspect, the present disclosure provides a method forcleaning an object. The method comprises applying a detergentcomposition to the object, thereby cleaning the object. The detergentcomposition comprises, based on the total weight of the composition, atleast 0.001% by weight of an antimicrobial agent, at least 0.01% byweight of a hydrotrope, and an enzyme.

It is understood that the inventions described in this specification arenot limited to the examples provided in this Summary. Various otheraspects are described and exemplified herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure contains at least one drawing executed in color.Copies of the present disclosure with color drawing(s) will be providedby the Office upon request and payment of the necessary fee.

The features and advantages of the examples, and the manner of attainingthem, will become more apparent and the examples will be betterunderstood by reference to the following description of examples takenin conjunction with the accompanying drawings, wherein:

FIG. 1 is a depiction of a system for treatment of an object utilizing adetergent composition according to the present disclosure.

FIG. 2A-D shows photographs of plastic or stainless steel couponstreated with a diluted detergent composition according to the presentdisclosure.

FIG. 2A shows a photograph of a stainless steel coupon treated with adiluted detergent composition according to the present disclosure thatwas supplemented with chlorhexidine gluconate (CHG).

FIG. 2B shows a photograph of a plastic coupon treated with a diluteddetergent composition according to the present disclosure that wassupplemented with CHG.

FIG. 2C shows a photograph of a stainless steel coupon treated with adiluted detergent composition according to the present disclosure thatwas not supplemented with CHG.

FIG. 2D shows a photograph of a plastic coupon treated with a diluteddetergent composition according to the present disclosure that was notsupplemented with CHG.

FIG. 3A-D shows photographs of plastic or stainless steel couponstreated with a diluted detergent composition, C1.

FIG. 3A shows a photograph of a stainless steel coupon treated with adiluted detergent composition, C1, which was supplemented with CHG.

FIG. 3B shows a photograph of a plastic coupon treated with a diluteddetergent composition, C1, which was supplemented with CHG.

FIG. 3C shows a photograph of a stainless steel coupon treated with adiluted detergent composition, C1, which was not supplemented with CHG.

FIG. 3D shows a photograph of a plastic coupon treated with a diluteddetergent composition, C1, which was not supplemented with CHG.

FIG. 4A-D shows photographs, when available, of plastic or stainlesssteel coupons treated with a diluted detergent composition, C2.

FIG. 4A indicates that CHG was insoluble in a diluted detergentcomposition, C2.

FIG. 4B indicates that CHG was insoluble in a diluted detergentcomposition, C2.

FIG. 4C shows a photograph of a stainless steel coupon treated with adiluted detergent composition, C2, which was not supplemented with CHG.

FIG. 4D shows a photograph of a plastic coupon treated with a diluteddetergent composition, C2, which was not supplemented with CHG.

FIG. 5A-D shows photographs, when available, of plastic or stainlesssteel coupons treated with a diluted detergent composition, C3.

FIG. 5A indicates that CHG was insoluble in a diluted detergentcomposition, C3.

FIG. 5B indicates that CHG was insoluble in a diluted detergentcomposition, C3.

FIG. 5C shows a photograph of a stainless steel coupon treated with adiluted detergent composition, C3, which was not supplemented with CHG.

FIG. 5D shows a photograph of a plastic coupon treated with a diluteddetergent composition, C3, which was not supplemented with CHG.

FIG. 6A-D shows photographs of plastic or stainless steel couponstreated with a diluted detergent composition, C4.

FIG. 6A shows a photograph of a stainless steel coupon treated with adiluted detergent composition, C4, which was supplemented with CHG.

FIG. 6B shows a photograph of a plastic coupon treated with a diluteddetergent composition, C4, which was supplemented with CHG.

FIG. 6C shows a photograph of a stainless steel coupon treated with adiluted detergent composition, C4, which was not supplemented with CHG.

FIG. 6D shows a photograph of a plastic coupon treated with a diluteddetergent composition, C4, which was not supplemented with CHG.

FIG. 7A-D shows photographs of plastic or stainless steel couponstreated with a diluted detergent composition, C5.

FIG. 7A shows a photograph of a stainless steel coupon treated with adiluted detergent composition, C5, which was supplemented with CHG.

FIG. 7B shows a photograph of a plastic coupon treated with a diluteddetergent composition, C5, which was supplemented with CHG.

FIG. 7C shows a photograph of a stainless steel coupon treated with adiluted detergent composition, C5, which was not supplemented with CHG.

FIG. 7D shows a photograph of a plastic coupon treated with a diluteddetergent composition, C5, which was not supplemented with CHG.

FIG. 8A-D shows photographs, when available, of plastic or stainlesssteel coupons treated with a diluted detergent composition, C6.

FIG. 8A indicates that CHG was insoluble in a diluted detergentcomposition, C6.

FIG. 8B indicates that CHG was insoluble in a diluted detergentcomposition, C6.

FIG. 8C shows a photograph of a stainless steel coupon treated with adiluted detergent composition, C6, which was not supplemented with CHG.

FIG. 8D shows a photograph of a plastic coupon treated with a diluteddetergent composition, C6, which was not supplemented with CHG.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate certain examples, in one form, and such exemplifications arenot to be construed as limiting the scope of the examples in any manner.

DETAILED DESCRIPTION

Certain exemplary aspects of the present disclosure will now bedescribed to provide an overall understanding of the principles of thecomposition, function, manufacture, and use of the compositions andmethods disclosed herein. One or more examples of these aspects areillustrated in the accompanying drawing. Those of ordinary skill in theart will understand that the compositions and methods specificallydescribed herein and illustrated in the accompanying drawings arenon-limiting exemplary aspects and that the scope of the variousexamples of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryaspect may be combined with the features of other aspects. Suchmodifications and variations are intended to be included within thescope of the present invention.

Reference throughout the specification to “various examples,” “someexamples,” “one example,” or “an example”, or the like, means that aparticular feature, structure, or characteristic described in connectionwith the example is included in at least one example. Thus, appearancesof the phrases “in various examples,” “in some examples,” “in oneexample”, or “in an example”, or the like, in places throughout thespecification are not necessarily all referring to the same example.Furthermore, the particular features, structures, or characteristics maybe combined in any suitable manner in one or more examples. Thus, theparticular features, structures, or characteristics illustrated ordescribed in connection with one example may be combined, in whole or inpart, with the features structures, or characteristics of one or moreother examples without limitation. Such modifications and variations areintended to be included within the scope of the present examples.

In this specification, unless otherwise indicated, all numericalparameters are to be understood as being prefaced and modified in allinstances by the term “about”, in which the numerical parameters possessthe inherent variability characteristic of the underlying measurementtechniques used to determine the numerical value of the parameter. Atthe very least, and not as an attempt to limit the application of thedoctrine of equivalents to the scope of the claims, each numericalparameter described herein should at least be construed in light of thenumber of reported significant digits and by applying ordinary roundingtechniques.

Also, any numerical range recited herein includes all sub-rangessubsumed within the recited range. For example, a range of “1 to 10”includes all sub-ranges between (and including) the recited minimumvalue of 1 and the recited maximum value of 10, that is, having aminimum value equal to or greater than 1 and a maximum value equal to orless than 10. Any maximum numerical limitation recited in thisspecification is intended to include all lower numerical limitationssubsumed therein and any minimum numerical limitation recited in thisspecification is intended to include all higher numerical limitationssubsumed therein. Accordingly, Applicant reserves the right to amendthis specification, including the claims, to expressly recite anysub-range subsumed within the ranges expressly recited. All such rangesare inherently described in this specification such that amending toexpressly recite any such sub-ranges would comply with the requirementsof 35 U.S.C. § 112 and 35 U.S.C. § 132(a).

The present disclosure relates to compositions for treatment and methodsof making and using those compositions. Objects of the presentdisclosure can undergo a treatment process as set forth herein toprevent cross-contamination and the spread of disease. As used herein, a“treatment process” may be a cleaning process, a disinfecting process,the like, and combinations thereof. A treatment process may be eithermanual, automated, or some combination thereof, and may utilize atreatment agent. As used herein, a “treatment agent” can comprise atleast one of a cleaning agent and an antimicrobial agent. As used hereina “cleaning process” means a treatment process employing a cleaningagent that removes and/or eliminates debris such as, for example, a bodyfluid (e.g., blood, urine, saliva) a dirt, a dust, a particle, an oil, aprotein, a carbohydrate, and the like. As used herein, a “cleaningagent” means a type of treatment agent that removes and/or eliminatesdebris during a cleaning process such as, for example, a surfactantand/or a detergent.

A disinfecting process can remove and/or eliminate a bioburden from anobject. A bioburden may be, for example, a bacterium (e.g.,mycobacterium, bacterial spores), an archaeon, a eukaryote, a virus, afungus, and/or other forms of biological agents. Bacterial spores (e.g.,endospores) are a form of bacteria which are dormant and highlyresistive to physical and chemical degradation. As used herein, a“disinfecting process” means a treatment process that substantiallyremoves a bioburden. As used herein, “substantially remove” means thatat least 99% of the bioburden has been removed from the object such as,for example, at least 99.9% of the bioburden, at least 99.99% of thebioburden, at least 99.999% of the bioburden, or at least 99.9999% ofthe bioburden has been removed from the object. The disinfection processmay include, for example, the addition of heat, an antimicrobial agent,irradiation, pressure, and combinations thereof. The antimicrobial agentmay comprise a chemical capable of disinfection.

As used herein, a “component” of the detergent composition of thepresent disclosure is meant to mean any chemical substance that can beadded and/or can be a part of the detergent composition. For example, acomponent of the detergent composition can be water, an alcohol, anantimicrobial agent, a hydrotrope, a surfactant, a buffer, a solvent, anenzyme, a chelating agent, a salt, the like, and combinations thereof.

Detergent compositions comprising an enzyme can aid in cleaning anobject. The enzyme can remove and/or eliminate debris. However, theenzyme, by itself, may not provide a sufficient reduction of bioburdento disinfect an object. Thus, an additional disinfecting processemploying an antimicrobial agent can be performed simultaneously with orsubsequent to the first cleaning step to prepare the object forsubsequent use.

However, it was previously believed by those of ordinary skill in theart that an antimicrobial agent reduces the enzymatic activity of theenzyme of the detergent composition, possibly via denaturation of theenzyme's three-dimensional structure, thereby adversely affecting anddiminishing the ability of the enzyme to remove and/or eliminate debrisand/or bioburden. Additionally, the antimicrobial agent was thought tosimilarly denature elements of debris and/or bioburden making them lesslikely to be removed during a treatment process. Thus, previously, itwas believed that an antimicrobial agent was incompatible with adetergent comprising an enzyme.

Surprisingly, it has been found that the addition of an antimicrobialagent to a detergent composition in combinations and/or amounts providedherein can enable a detergent composition already used for cleaning toalso be used for disinfection processes. Thus, it has been found thatthe cleaning and disinfecting processes can be combined, and theefficiency of treating objects can be increased. The cleaning anddisinfecting can be combined.

Accordingly, provided herein are detergent compositions comprising anantimicrobial agent and an enzyme, methods of making the detergentcompositions, and methods of using the detergent compositions. Thedetergent compositions of the present disclosure can comprise a cleaningagent and an antimicrobial agent. The detergent compositions of thepresent disclosure can comprise an enzyme that can effectively removeand/or eliminate debris and/or bioburden from an object in the presenceof an antimicrobial agent that can disinfect the object. The detergentcompositions set forth herein can clean and disinfect the object.

In one example, the present disclosure provides a detergent compositioncomprising an antimicrobial agent, an enzyme, and a hydrotrope.

The antimicrobial agent can comprise at least one of a biguanidecompound and a quaternary ammonium compound. Quaternary ammoniumcompounds comprise a nitrogen atom covalently bonded to four R-groups.For example, quaternary ammonium compounds can comprise Formula 1 below.

where R₁₋₄ are each an alkyl or aryl group, and R₁₋₄ may each be thesame or different.

As used herein a “biguanide compound” means at least one of abisbiguanide compound, a biguanide compound, and a polybiguanidecompound. Polybiguanide compounds can comprise Formula 2 below.

where R₅ is an alkyl or an aryl, R₅ may be halogen substituted; and

-   -   n is in a range of 1 to 50.

For example, when n is 2, the polybiguanide compounds can compriseFormula 3 below.

where R₆ and R₅ are each an alkyl or an aryl, R₆ and R₅ may be halogensubstituted, and R₆ and R₅ may be the same or different; and

-   -   R₇ is an alkyl comprising 3 to 10 carbon atoms.

The antimicrobial agent in the detergent compositions of the presentdisclosure can remove and/or eliminate bioburden. The antimicrobialagent can disinfect an object (e.g., via disruption of biologicalmembranes or denaturation of proteins). The antimicrobial agent can bepresent in the detergent compositions of the present disclosure in anyeffective amount. For example, the detergent composition can comprise atleast 0.001% antimicrobial agent by weight based on the total weight ofthe detergent composition such as, for example, at least 0.01%antimicrobial agent by weight, at least 0.1% antimicrobial agent byweight, at least 0.5% antimicrobial agent by weight, at least 1%antimicrobial agent by weight, at least 2% antimicrobial agent byweight, at least 3% antimicrobial agent by weight, at least 4%antimicrobial agent by weight, at least 5% antimicrobial agent byweight, at least 10% antimicrobial agent by weight, or at least 15%antimicrobial agent by weight. The detergent composition can comprise20% or less antimicrobial agent by weight based on the total weight ofthe detergent composition such as, for example, 15% or lessantimicrobial agent by weight, 10% or less antimicrobial agent byweight, 5% or less antimicrobial agent by weight, 4% or lessantimicrobial agent by weight, 3% or less antimicrobial agent by weight,2% or less antimicrobial agent by weight, 1% or less antimicrobial agentby weight, 0.5% or less antimicrobial agent by weight, 0.1% or lessantimicrobial agent by weight, or 0.01% or less antimicrobial agent byweight. The detergent composition can comprise 0.001% to 20%antimicrobial agent by weight based on the total weight of the detergentcomposition such as, for example, 0.001% to 5% antimicrobial agent byweight, 0.01% to 5% antimicrobial agent by weight, 0.1% to 5%antimicrobial agent by weight, 1% to 5% antimicrobial agent by weight,1% to 10% antimicrobial agent by weight, 5% to 15% antimicrobial agentby weight, or 1% to 20% antimicrobial agent by weight.

The biguanide compound, if present, can comprise at least one ofchlorhexidine (e.g.,N,N″″1,6-Hexanediylbis[N′-(4-chlorophenyl)(imidodicarbonimidicdiamide)]), alexidine (e.g.,1,1′-(1,6-Hexanediyl)bis{2-[N′-(2-ethylhexyl)carbamimidoyl]guanidine}),octenidine, (e.g.,N-octyl-1-[10-(4-octyliminopyridin-1-yl)decyl]pyridin-4-imine), apolybiguanide such as Polyhexanide (polyhexamethylene biguanide), and asalt of any thereof.

The quaternary ammonium compound, if present, can comprise, for example,at least one of n-alkyl dimethyl benzyl ammonium chloride, didecyldimethyl ammonium chloride, and n-alkyl dimethyl ethylbenzyl ammoniumchloride, and various other suitable quaternary ammonium compounds asknown in the art. The quaternary ammonium compound can comprise n-alkyldimethyl benzyl ammonium chloride and didecyl dimethyl ammoniumchloride. The quaternary ammonium compound may be BTC 1210®, availablefrom Stepan Company, Northfield, Ill. BTC 1210® can comprise n-alkyldimethyl benzyl ammonium chloride and didecyl dimethyl ammoniumchloride.

The detergent composition can further comprise a hydrotrope. Ahydrotrope is a substance that can solubilize hydrophobic substanceswhile in aqueous solution. Hydrotropes generally do not form micelles asreadily as surfactants because the hydrophobic moieties of hydrotropesare too small to do so. The hydrotrope can be, for example, an anionic,cationic, or nonionic hydrotrope. The hydrotrope can be inorganic ororganic and can comprise surfactant activity. Organic solvents can besulfonated to create a sulfonic acid, which can then be neutralized tocreate a hydrotrope salt. The hydrotrope can comprise at least one of analkanoic acid (e.g., sulfonic acid, carboxylic acid), an aromaticsulfonic acid, an aromatic carboxylic acid, and a salt of any thereof.The salt of the alkanoic acid can be, for example, a sodium alkanoatesalt. The hydrotrope can comprise a toluenesulfonyl functional group.The hydrotrope can comprise at least one of urea, p-toluenesulfonic acid(e.g., 4-methylbenzene-1-sulfonic acid), xylene sulfonic acid (e.g.,2,5-dimethylbenzenesulfonic acid), cumene sulfonic acid (e.g., 2(or4)-(isopropyl)benzenesulphonic acid), and a salt of any thereof. If ananionic hydrotrope is employed, the hydrotrope can comprise at least oneof Cola® Trope INC, Cola® Trope OD, and Cola® Trope CA. All three Cola®Trope substances are available from Colonial Chemical, Inc., SouthPittsburgh, Tenn., USA. All three Cola® Trope substances comprise sodiumalkanoate.

The hydrotrope can be present in the detergent compositions of thepresent disclosure in any effective amount. For example, the detergentcompositions of the present disclosure can comprise at least 0.01%hydrotrope by weight based on the total weight of the detergentcomposition such as, for example, at least 0.1% hydrotrope by weight, atleast 1% hydrotrope by weight, at least 5% hydrotrope by weight, atleast 10% hydrotrope by weight, at least 15% hydrotrope by weight, atleast 20% hydrotrope by weight, or at least 25% hydrotrope by weight.The detergent composition can comprise 30% or less hydrotrope by weightbased on the total weight of the detergent composition such as, forexample, 25% or less hydrotrope by weight, 20% or less hydrotrope byweight, 15% or less hydrotrope by weight, 10% or less hydrotrope byweight, 5% or less hydrotrope by weight, 1% or less hydrotrope byweight, or 0.1% or less hydrotrope by weight. The detergent compositioncan comprise 0.01% to 30% hydrotrope by weight based on the total weightof the detergent composition such as, for example, 0.1% to 30%hydrotrope by weight, 1% to 30% hydrotrope by weight, 5% to 20%hydrotrope by weight, 5% to 15% hydrotrope by weight, 10% to 20%hydrotrope by weight, or 10% to 15% hydrotrope by weight.

The detergent composition can further comprise an enzyme component. Theenzyme component can be in the form of a liquid enzyme solution or adry, powdered component (e.g., lyophilized). The enzyme can removeand/or eliminate debris via enzymatic digestion (e.g., decomposition) ofthe debris. The enzyme can comprise a hydrolase enzyme. The hydrolaseenzyme can break chemical bonds in the debris and/or bioburden, by theaddition of a water molecule (e.g., hydrolysis). For example, thehydrolase enzyme can remove and/or eliminate lipids, carbohydrates,proteins, peptides, and nucleic acids from an object. The hydrolaseenzyme can comprise at least one of a lipase, a protease, a peptidase,an amylase, a glycosidase, a cellulase, a DNAse, and a nuclease. Theenzyme can be selected based on a pH of a detergent composition and/oreffectiveness on removing and/or eliminating a select debris and/orbioburden.

The enzyme can be present in the detergent compositions of the presentdisclosure in any effective amount. For example, the enzyme can compriseat least 0.001% active enzyme protein by weight based on the total dryweight of the enzyme such as, for example, at least 0.01% active enzymeprotein, at least 0.1% active enzyme protein, at least 1% active enzymeprotein, at least 5% active enzyme protein, at least 10% active enzymeprotein, or at least 15% active enzyme protein. The enzyme can comprise20% or less active enzyme protein by weight based on the total dryweight of the enzyme such as, for example, 15% or less active enzymeprotein, 10% or less active enzyme protein, 5% or less active enzymeprotein, 1% or less active enzyme protein, 0.1% or less active enzymeprotein, or 0.01% or less active enzyme protein. The enzyme can comprise0.001% to 20% active enzyme protein by weight based on the total dryweight of the enzyme such as, for example, 0.01% to 20% active enzymeprotein, 0.1% to 20% active enzyme protein, 0.1% to 10% active enzymeprotein, 1% to 10% active enzyme protein, or 1% to 5% active enzymeprotein.

The pH the detergent composition can be adjusted based on the enzymesuch that the enzyme has an enzymatic activity suitable to remove and/oreliminate debris and/or bioburden. For example, the detergentcomposition can have a pH of at least 6.0 such as, for example, at least6.5, at least 7.0, at least 7.5, at least 8.0, at least 9, at least 10,or at least 11. The detergent composition can have a pH of less than 12such as, for example, less than 11, less than 10, less than 9.0, lessthan 8, less than 7.5, less than 7.0, or less than 6.5. The detergentcomposition can have a pH in a range of 6 to 12 such as, for example, 6to 8, 7 to 10, 7 to 9, or 8 to 11.

The pH of the detergent composition can be adjusted by adding a pHadjusting agent. The pH adjusting agent can be, for example, at leastone of an acid and a base. The pH adjusting agent can comprise, forexample, at least one of sodium hydroxide, potassium hydroxide,monoethanolamine, diethanolamine, and triethanolamine. The detergentcomposition can comprise any effective amount of pH adjusting agent toachieve the desired pH. For example, the detergent composition cancomprise 2% or less of a pH adjusting agent based on the total weight ofthe detergent composition such as, for example, 1% or less of a pHadjusting agent, 0.5% or less of a pH adjusting agent, 0.1% or less of apH adjusting agent, 0.01% or less of a pH adjusting agent, 0.001% orless of a pH adjusting agent. The detergent composition can comprise atleast 0.0001% of a pH adjusting agent based on the total weight of thedetergent composition such as, for example, at least 0.001% of a pHadjusting agent, at least 0.01% of a pH adjusting agent, at least 0.1%of a pH adjusting agent, at least 0.5% of a pH adjusting agent, or atleast 1% of a pH adjusting agent. The detergent composition can comprise0.0001% to 2% of a pH adjusting agent based on the total weight of thedetergent composition such as, for example, 0.1% to 2% of a pH adjustingagent, 0.01% to 2% of a pH adjusting agent, or 0.001% to 1% of a pHadjusting agent.

Detergent compositions of the present disclosure can further comprise aboron-containing compound such as, for example, boric acid (e.g.,H₃BO₃), borax (e.g., mineral salts of boric acid, including commerciallyprovided, partially dehydrated salts), and other similarboron-containing compounds. These boron-containing compounds can improvethe pH buffering, cleaning performance, and enzyme stability of adetergent composition. Surprisingly, however, it has been found thatexamples of the detergent compositions of the present disclosure do notrequire boron-containing compounds for aspects of their performance suchas, for example, enzyme stability, pH buffering, and/or cleaningperformance. Thus, it may be advantageous for the detergent compositionsof the present disclosure to comprise a limited amount of aboron-containing compound, only incidental (i.e., trace) amounts of aboron-containing compound, no measurable boron-containing compound atall, or no intentionally added boron-containing compound. For example,detergent compositions of the present disclosure can comprise 0.1% orless by weight of a boron-containing compound based on the total weightof the detergent composition such as, for example, 0.01% or less byweight of a boron-containing compound, 0.001% or less by weight of aboron-containing compound, 0.0001% or less by weight of aboron-containing compound, or no measurable boron-containing compound.

The detergent composition of the present disclosure can further comprisea buffer component. The buffer can stabilize the pH of the detergentcomposition and can maintain a chemical environment that can becompatible with other components of the detergent composition such as,for example, the enzyme. The buffer can comprise, for example, aconjugate acid/base pair. The conjugate acid/base pair can comprise azwitterion compound. The zwitterion compound can accept and donatehydrogen ions in response to pH changes, thereby maintaining aconsistent pH. The zwitterion compound can comprise an amino acid, suchas, for example, glycine. The conjugate acid/conjugate base pair cancomprise, for example, at least one of tris(hydroxymethyl)aminomethane,a carbonate buffer, and a phosphate buffer. If present, the buffer maybe present in the detergent compositions of the present disclosure inany effective amount. For example, the detergent composition cancomprise 10% or less by weight of buffer based on the total weight ofthe detergent composition such as, for example, 5% or less buffer byweight, 3% or less buffer by weight, 1% or less buffer by weight, 0.5%or less buffer by weight, 0.1% or less buffer by weight, 0.01% or lessbuffer by weight, or 0.001% or less buffer by weight. The detergentcompositions of the present disclosure can comprise at least 0.0001% byweight of buffer based on the total weight of the detergent compositionsuch as, for example, at least 0.001% by weight of buffer, at least0.01% by weight of buffer, at least 0.1% by weight of buffer, at least0.5% by weight of buffer, at least 1% by weight of buffer, at least 3%buffer by weight, or at least 5% by weight of buffer. The detergentcompositions of the present disclosure can comprise 0.0001% to 10% byweight of buffer based on the total weight of the detergent compositionsuch as, for example, 0.001% to 5% by weight of buffer, 0.01% to 5% byweight of buffer, 0.1% to 5% by weight of buffer, 0.5% to 3% by weightof buffer, or 0.5% to 2% by weight of buffer.

The detergent composition of the present disclosure can further comprisea solvent. The solvent can assist in removing and/or eliminating debrisfrom the object. The solvent can enhance solubility of the components ofthe detergent composition and/or the solubility of the debris and/orbioburden. Enhancing the solubility of the debris and/or bioburden canfacilitate removal and/or elimination of the debris and/or bioburden.The solvent can comprise, for example, at least one of a glycol ether,propylene glycol, ethylene glycol, methanol, ethanol, isopropanol, andn-propanol. The glycol ether can comprise, for example, at least one of2-ethoxyethanol, 2-butoxyethanol, methyl ether, and propylene glycoln-butyl ether. If present, the solvent may be present in the detergentcompositions of the present disclosure in any effective amount. Forexample, the detergent composition can comprise at least 0.01% solventby weight based on the total weight of the detergent composition suchas, for example, at least 0.1% solvent by weight, at least 1% solvent byweight, at least 5% solvent by weight, at least 10% solvent by weight,at least 11% solvent by weight, at least 12% solvent by weight, at least13% solvent by weight, at least 14% solvent by weight, at least 15%solvent by weight, at least 20% solvent by weight, at least 30% solventby weight, or at least 40% solvent by weight. The detergent compositioncan comprise 50% or less solvent by weight based on the total weight ofthe detergent composition such as, for example, 40% or less solvent byweight, 30% or less solvent by weight, 20% or less solvent by weight,15% or less solvent by weight, 14% or less solvent by weight, 13% orless solvent by weight, 12% or less solvent by weight, 11% or lesssolvent by weight, 10% or less solvent by weight, 5% or less solvent byweight, 1% or less solvent by weight, or 0.1% or less solvent by weight.The detergent composition can comprise 0.01% to 50% solvent by weightbased on the total weight of the detergent composition such as, forexample, 0.1% to 5% solvent by weight, 5% to 20% solvent by weight, 10%to 20% solvent by weight, or 10% to 15% solvent by weight.

The detergent compositions of the present disclosure can furthercomprise a salt. The salt can increase removal and/or elimination ofdebris by the enzyme. The salt can act as an enzyme stabilizer. The saltcan be organic or inorganic and can comprise, for example, at least oneof calcium chloride, potassium chloride, sodium chloride, sodiumcitrate, and magnesium chloride. If present, the salt may be present inthe detergent compositions of the present disclosure in any effectiveamount. For example, the detergent composition can comprise 10% or lessof salt by weight, based on the total weight of the detergentcomposition such as, for example, 5% or less salt by weight, 4% or lesssalt by weight, 3% or less salt by weight, 2% or less salt by weight, 1%or less salt by weight, 0.5% or less salt by weight, 0.1% or less saltby weight, or 0.01% or less salt by weight. The detergent compositioncan comprise at least 0.001% of salt by weight, based on the totalweight of the detergent composition such as, for example, at least 0.01%of salt by weight, at least 0.1% of salt by weight, at least 0.5% ofsalt by weight, at least 1% of salt by weight, at least 2% of salt byweight, at least 3% of salt by weight, at least 4% of salt by weight, orat least 5% of salt by weight. The detergent composition can comprise0.001% to 10% of salt by weight, based on the total weight of thedetergent composition such as, for example, 0.1% to 5% of salt by weightor 0.001% to 0.1%.

The detergent composition of the present disclosure can further comprisea chelating agent. The chelating agent can increase cleaning by thedetergent composition. For example, the chelating agent can chelate ametal ion and/or chelate at the pH of the detergent composition. Thechelating agent can be a non-phosphate chelator and/or can bebiodegradable. The chelating agent can comprise, for example, at leastone of, methylglycindiacetic acid, N,N-bis(carboxymethyl)-L-glutamicacid, citric acid, a gluconic acid, N-(1,2-dicarboxyethyl)aspartic acid,ethylenediamine-N, N′-disuccinic acid, and a salt of any thereof. Thechelating agent can comprise Trilon M®, available from BASF, SE,Ludwigshafen, Germany. Trilon M® can comprise trisodium salt ofmethylglycindiacetic acid. The chelating agent can comprise Dissolvine®GL-47-S, available from Akzo Nobel N.V., Amsterdam, Netherlands.Dissolvine® GL-47-S can comprise TetrasodiumN,N-bis(carboxymethyl)-L-glutamate. The chelating agent can compriseBaypure® CX100, available from Lanxess AG, Cologne, Germany. Baypure®CX100 can comprise N-(1,2-dicarboxyethyl)aspartic acid as a sodium salt(e.g., Tetrasodium iminodisuccinate).

If present, the chelating agent may be present in the detergentcompositions of the present disclosure in any effective amount. Forexample, the detergent composition can comprise 5% or less of chelatingagent by weight based on the total weight of the detergent compositionsuch as, for example, 4% or less of chelating agent by weight, 3% orless of chelating agent by weight, 2% or less of chelating agent byweight, 1% or less of chelating agent by weight, 0.1% or less ofchelating agent by weight, or 0.01% or less of chelating agent byweight. The detergent composition can comprise at least 0.005% ofchelating agent by weight based on the total weight of the detergentcomposition such as, for example, at least 0.01% of chelating agent byweight, at least 0.1% of chelating agent by weight, at least 1% ofchelating agent by weight, at least 2% of chelating agent by weight, atleast 3% of chelating agent by weight, or at least 4% of chelating agentby weight. The detergent composition can comprise 0.005% to 5% ofchelating agent by weight based on the total weight of the detergentcomposition such as, for example, 0.005% to 0.1% of chelating agent byweight, 0.5% to 3% of chelating agent by weight, 1% to 3% of chelatingagent by weight.

The detergent composition of the present disclosure can comprisesurfactants in addition to the hydrotrope, such as, for example, anon-ionic surfactant. The non-ionic surfactant can increase thesolubility of debris and/or bioburden, and aid in the removal of thedebris and/or bioburden from the object. The non-ionic surfactant can below foaming. Non-ionic surfactants can comprise, for example, at leastone of a fatty alcohol ethylene oxide/propylene oxide copolymerderivative, a polyoxyethylene-polyoxypropylene block copolymer, andvarious other non-ionic surfactants as known in the art. The non-ionicsurfactant may be Dehypon® LS 54 available from BASF SE, Ludwigshafen,Germany. Dehypon® LS 54 can comprise a C12-15 fatty alcohol ethyleneoxide/propylene oxide copolymer derivative. The non-ionic surfactant maybe Dehypon® LS 36 available from BASF SE, Ludwigshafen, Germany.Dehypon® LS 36 can comprise a C12-14 fatty alcohol ethyleneoxide/propylene oxide copolymer derivative. The non-ionic surfactant maybe Pluronic® L62 available from BASF SE, Ludwigshafen, Germany.Pluronic® L62 can comprise a polyoxyethylene-polyoxypropylene blockcopolymer.

If present, the non-ionic surfactant may be present in the detergentcompositions of the present disclosure in any effective amount. Forexample, the detergent composition can comprise at least 0.005% ofnon-ionic surfactant by weight based on the total weight of thedetergent composition such as, for example, at least 0.01% of non-ionicsurfactant by weight, at least 0.1% of non-ionic surfactant by weight,at least 1% of non-ionic surfactant by weight, at least 2% of non-ionicsurfactant by weight, at least 3% of non-ionic surfactant by weight, atleast 4% of non-ionic surfactant by weight, at least 5% of non-ionicsurfactant by weight, at least 6% of non-ionic surfactant by weight, orat least 7% of non-ionic surfactant by weight. The detergent compositioncan comprise 10% or less of non-ionic surfactant by weight based on thetotal weight of the detergent composition such as, for example, 7% orless of non-ionic surfactant by weight, 6% or less of non-ionicsurfactant by weight, 5% or less of non-ionic surfactant by weight, 4%or less of non-ionic surfactant by weight, 3% or less of non-ionicsurfactant by weight, 2% or less of non-ionic surfactant by weight, 1%or less of non-ionic surfactant by weight, 0.1% or less of non-ionicsurfactant by weight, or 0.01% or less of non-ionic surfactant byweight. The detergent composition can comprise 0.005% to 10% ofnon-ionic surfactant by weight based on the total weight of thedetergent composition such as, for example, 0.01% to 1% of non-ionicsurfactant by weight, 0.5% to 7% of non-ionic surfactant by weight, 0.5%to 6% of non-ionic surfactant by weight, 1% to 6% of non-ionicsurfactant by weight, or 2% to 6% of non-ionic surfactant by weight.

The detergent compositions of the present disclosure can furthercomprise at least 10% by weight of water based on the total weight ofthe detergent composition such as, for example, at least 25% water byweight, at least 35% water by weight, at least 40% water by weight, atleast 45% water by weight, at least 50% water by weight, at least 55%water by weight, or at least 60% water by weight. The water content ofthe detergent composition can be in a range of 20% to 60% by weightbased on the total weight of the detergent composition such as, forexample, 25% to 55% by weight, 30% to 55% by weight, or 34% to 50% waterby weight. The water employed can be any suitable type of water known inthe art such as, for example, at least one of de-ionized water,distilled water, reverse osmosis treated water, filtered water, sterilewater, tap water, and the like.

It is understood that a detergent composition of the present disclosurecan be made in a concentrated or diluted form. Accordingly, the presentdisclosure provides examples wherein the percentage by weight, based onthe total weight of the composition, of various components of thedetergent composition are at relatively high values, and exampleswherein the percentage by weight, based on the total weight of thecomposition, of various components of the detergent composition are atrelatively low values. Compositions of relatively high and relativelylow concentrations are contemplated herein and may serve certainintended purposes.

The detergent compositions of the present disclosure can be stored for aperiod of time before use in a cleaning and/or disinfecting. Afterstorage, the detergent compositions can maintain an enzymatic activityof an enzyme suitable for removing and/or eliminating debris and/orbioburden. For example, the detergent compositions of the presentdisclosure can comprise a four week storage stability at 40 degreesCelsius suitable to maintain the enzymatic activity of the enzyme of atleast 40% of an initial enzymatic activity of the enzyme prior tostorage such as, for example, at least 50% of the initial enzymaticactivity, at least 60% of the initial enzymatic activity, at least 70%of the initial enzymatic activity, at least 80% of the initial enzymaticactivity, at least 90% of the initial enzymatic activity, or at least95% of the initial enzymatic activity prior to storage. The detergentcompositions of the present disclosure can comprise a four week storagestability at 30 degrees Celsius suitable to maintain an enzymaticactivity of the enzyme of at least 40% of an initial enzymatic activityof the enzyme prior to storage such as, for example, at least 50% of theinitial enzymatic activity, at least 60% of the initial enzymaticactivity, at least 70% of the initial enzymatic activity, at least 80%of the initial enzymatic activity, at least 90% of the initial enzymaticactivity, or at least 95% of the initial enzymatic activity. Thedetergent compositions of the present disclosure can comprise a fourweek storage stability at 25 degrees Celsius suitable to maintain anenzymatic activity of the enzyme of at least 40% of an initial enzymaticactivity of the enzyme in the enzyme prior to storage such as, forexample, at least 50% of the initial enzymatic activity, at least 60% ofthe initial enzymatic activity, at least 70% of the initial enzymaticactivity, at least 80% of the initial enzymatic activity, at least 90%of the initial enzymatic activity, or at least 95% of the initialenzymatic activity.

The present disclosure also provides methods of making a detergentcomposition. The components of the detergent composition set forthherein can be combined in any suitable manner and in the various amountsset forth herein. For example, the antimicrobial agent, the hydrotrope,and the enzyme can be combined in any manner in the amounts set forthherein to form the detergent compositions of the present disclosure. Forexample, based on the total weight of the detergent composition, atleast 10% by weight of water, at least 0.001% by weight of theantimicrobial agent, at least 0.01% by weight of the hydrotrope, and theenzyme can be combined to form the detergent composition. The componentsof the detergent compositions of the present disclosure can be combinedin any order. For example, combining the water, antimicrobial agent, andthe hydrotrope can occur prior to adding the enzyme. Also, optionalcomponents provided herein can be added to the detergent compositions ofthe present disclosure. For example, at least one of the buffer, thechelating agent, the solvent, the non-ionic surfactant, and the saltdescribed herein can be added to the detergent compositions of thepresent disclosure. The pH of the detergent composition can be adjustedto a pH suitable to maintain enzymatic activity of an enzyme. The pH canbe adjusted prior to adding the enzyme. When a dry, powdered detergentcomposition is desired, dry, powered components can be mixed together toform a powdered mixture and then surfactants can be mixed with, such assprayed onto (e.g., in a liquid form), the powdered mixture. Thepowdered mixture can be mixed until a desired homogeneity is achieved.

The components of the detergent compositions of the present disclosurecan be combined in various orders. For example, the components of thedetergent composition can be combined by adding each component one at atime, adding multiple components in a single step, or adding a portionof a component at multiple addition stages. For example, based on thetotal weight of the detergent composition, at least 10% by weight ofwater can be combined with at least 0.001% by weight of theantimicrobial agent, followed by at least 0.01% by weight of thehydrotrope. The buffer, if present, can then be added, followed by theaddition of the enzyme. Thereafter, the pH can be adjusted to a levelappropriate for the enzyme to retain enzymatic activity. Alternatively,the enzyme can be added after the pH of the detergent composition hasbeen adjusted.

The water, the antimicrobial agent, the hydrotrope, the non-ionicsurfactant, and the buffer can each be added in a single portion or inmultiple portions. For example, a first portion of the buffer can beadded to the water to form a first composition, the solvent can be addedto the first composition to form a second composition, and the remainingportion of the buffer can be added to the second composition to form athird composition. Then, the third composition can be combined with theantimicrobial agent, the hydrotrope, and the enzyme, in a single step,in series, or in some other combination, to form the detergentcomposition of the present disclosure. The enzyme can be the finalcomponent added.

A method for cleaning all or a portion of an object is also providedherein. For example, the object can be a reusable medical device suchas, for example, an endoscope, and the detergent composition can be usedto clean and disinfect the endoscope. The detergent composition of thepresent disclosure can clean and/or disinfect the object by removingdebris and/or bioburden, from the object. The method for cleaning theobject can comprise applying the detergent composition of the presentdisclosure to the object. As used herein, “applying” is meant to includeall or a portion of the object, including one or more surfaces of theobject, whether the surface of the object is an exterior surface, aninterior surface, or a cavity of the object. As set forth above, thedetergent composition can comprise the various components and amountsset forth herein. For example, based on the total weight of thedetergent composition, the detergent composition can comprise at least0.001% by weight of the antimicrobial agent, at least 0.01% by weight ofthe hydrotrope, and the enzyme. Application of the detergent compositionof the present disclosure thereby cleans the object. The detergentcomposition can be applied to the object by any suitable means. Forexample, applying the detergent composition of the present disclosure tothe object can comprise at least one of depositing, scrubbing, spraying,rolling, submerging, and/or agitating the detergent composition over,onto, or inside the object.

Before or during applying the detergent composition of the presentdisclosure to the object, the detergent composition can be diluted, ifnecessary, to a lower concentration. The dilution can be by a factor ofat least 5-fold, at least 10-fold, at least 20-fold, at least 50-fold,at least 100-fold, at least 200-fold, or any factor appropriate toachieve treatment of the object and/or conserve the detergentcomposition. The diluting can be automated or manual. The diluent cancomprise or consist of, for example, water in any type as alreadydescribed herein.

The detergent composition can be applied to the object manually orautomatically (e.g., mechanically) to clean and/or disinfect the object.After application, the detergent composition can be immediately removedfrom, or be allowed to remain on, the object for a period of time. Thedetergent composition and any remaining debris or bioburden can beremoved from the object by wiping, rinsing, drying, or combinationsthereof.

The cleaning and/or disinfecting can occur in a treatment system suchas, for example, an automated endoscope re-processor. Referring to FIG.1, the treatment system 100 can comprise a chamber 102 including a basin104 in fluid communication with a reservoir 106. The chamber 102 may beany suitable size and configuration to receive the object (not shown),and can be suitable to perform a treatment process on the object. Thechamber 102 can be at least one of a cleaning chamber and/or adisinfection chamber. The object can comprise an endoscope. Thetreatment system 100 can comprise an automated endoscope re-processor.

The reservoir 106 can be any suitable size and configuration to receivethe detergent composition of the present disclosure and can store thedetergent composition until the detergent composition can be output intothe basin 104. The basin 104 can be in fluid communication with thereservoir 106 via a treatment line 108 and can receive detergentcomposition from the reservoir 106. The treatment line 108 can receivethe detergent composition from the reservoir 106 and transport thedetergent composition to the basin 104. The treatment line 108 caninclude at least one of a tube, a valve, and a pump. The treatment line108 can control the amount of detergent composition provided to thebasin 104. For example, the detergent composition can be metered intothe basin 104 by the treatment line 108 until a select amount ofdetergent composition has been provided to the basin 104. The basin 104can be in fluid communication with a drain line 110 to remove detergentcomposition from the basin.

An object to be treated can be provided to the chamber 102 and subjectedto the treatment process therein. The treatment process can compriseproviding the detergent composition to the basin 104 and/or applying thedetergent composition to the object. For example, the detergentcomposition can be sprayed and/or deposited on the object by a spray arm(not shown) in the chamber 102. Thereafter, the object can be optionallywiped, rinsed, and/or dried and removed from the chamber 102.

Applying the detergent composition to the object can occur at anoperating temperature in a range of 15° C. to 60° C. such as, forexample, 15° C. to 50° C., 30° C. to 50° C., or 43° C. to 48° C. Theoperating temperature can be achieved through automation, such as in anautomated endoscope re-processor, a similar machine, or by heating thedetergent composition independent of an automated endoscopere-processor.

EXAMPLES

The present disclosure will be more fully understood by reference to thefollowing examples, which provide illustrative, non-limiting aspects ofthe invention. The examples describe the making of detergentcompositions and use thereof in cleaning and/or disinfecting.

Example 1

Detergent compositions F1-F6*, provided below, were manufactured asshown in Table 1. Glycine and calcium chloride were obtained from VWRInternational, Randor, Pa. Sodium hydroxide and 2-ethoxyethanol wereobtained from Sigma-Aldrich, St. Louis, Mo. Propylene glycol wasobtained from Ward's Science, Rochester, N.Y. Savinase® everis,Stainzyme® plus, and Lipex® everis were obtained from Novozymes A/S,Denmark. Savinase® everis comprises an alkaline protease having anactive enzyme protein of 2.5% to 5% by weight of the Savinase® solution.Stainzyme® plus comprises an alpha-amylase having active enzyme proteinof 1% to 2.5% by weight of the Stainzyme® solution. Lipex® everiscomprises a lipase. Savinase® everis, Stainzyme® plus, and Lipex® everiswere obtained in solution. BTC 1210® was obtained from Stepan Company,Northfield, Ill. Trilon M® was obtained from BASF, SE, Ludwigshafen,Germany. Dehypon® LS 54 was obtained from BASF SE, Ludwigshafen,Germany.

1.6 kilograms of each detergent composition F1-F6* was prepared. For thepreparation of each detergent compositions F1-F6*, glycine was added tode-ionized water and then sodium hydroxide and Trilon M® were added inorder respectively. The pH of the detergent composition was adjustedand/or maintained by addition of the glycine and the sodium hydroxide tothe detergent composition. If used (e.g., detergent compositions F1, F3,F4*, and F6*), 2-ethoxyethanol was added after the addition of theTrilon M®. Similarly, if used (detergent compositions F2, F3, F5*, andF6*), propylene glycol was added after the addition of the Trilon M® andthe optional addition of the 2-ethoxyethanol. Then, for detergentcompositions F4*-F6*, BTC® 1210 was added. Thereafter, for detergentcompositions F1-F6*, Dehypon® LS 54 and Calcium chloride were added inorder respectively. The enzyme solutions, Savinase® everis, Stainzyme®plus, and Lipex® everis were added last.

As shown in Table 1, detergent compositions F1 and F4* are similarexcept that F4* comprises BTC® 1210. Detergent compositions F2 and F5*are similar except that F5* comprises BTC® 1210. Detergent compositionsF3 and F6* are similar except that F6* comprises BTC® 1210.

TABLE 1 Weight percentage (wt. %) of each component of the detergentcompositions F1-F6* based on the total weight of the composition.Detergent Composition Component F1 F4* F2 F5* F3 F6* De-ionized 49.8444.842 49.842 44.842 39.842 34.842 Water (wt. %) Glycine (wt. %) 2 2 2 22 2 Sodium 0.098 0.098 0.098 0.098 0.098 0.098 Hydroxide (wt. %) TrilonM ® 1 1 1 1 1 1 (wt. %) 2-Ethoxyethanol 25 25 — — 25 25 (wt. %)Propylene glycol — — 25 25 10 10 (wt. %) BTC ® 1210 — 5 — 5 — 5 (wt. %)Dehypon ® 2 2 2 2 2 2 LS 54 (wt. %) Calcium chloride 0.06 0.06 0.06 0.060.06 0.06 (wt. %) Savinase ® 10 10 10 10 10 10 everis (wt. %)Stainzyme ® 5 5 5 5 5 5 plus (wt. %) Lipex ® everis 5 5 5 5 5 5 (wt. %)Final pH 8.99 8.77 8.95 8.86 8.98 8.85 *These detergent compositionscontain a quaternary ammonium compound.

Example 2

To determine the effects of quaternary ammonium compound presence onenzymatic activity, the detergent compositions F1-F6* were stored at 25degrees Celsius, 30 degrees Celsius, 40 degrees Celsius, and 50 degreesCelsius in duplicate for 4 weeks. At two weeks and four weeks, aliquotsof the stored detergent compositions F1-F6* were sampled and tested forthe enzymatic activity against a standard substrate. Enzyme activitiesof each aliquot were compared to initial activities of the detergentcompositions F1-F6* before storage. Surprisingly, as illustrated inTables 2-7 and described herein, the detergent compositionsF4*-F6*maintained an amount of enzymatic activity suitable to removeand/or eliminate debris and/or bioburden from an object after storage.

Results for Savinase® ever is are shown in Table 2 which shows enzymaticactivity data after 2 weeks of storage and Table 3 which shows enzymaticactivity data after 4 weeks of storage. Detergent compositions F4*-F6*maintained an amount of Savinase® enzyme activity suitable to cleanand/or disinfect an object at after storage for 4 weeks at 25 degreesCelsius, 30 degrees Celsius, and 40 degrees Celsius. Detergentcomposition F5* had an enhanced Savinase® storage stability compared todetergent composition F2 after storage for 4 weeks at 25 degreesCelsius, 30 degrees Celsius, and 40 degrees Celsius.

TABLE 2 Savinase ® enzymatic activity as a percentage of initialenzymatic activity after 2 weeks of storage Storage DetergentComposition Temperature F1 F4* F2 F5* F3 F6* 25° C. 100 89 92 96 96 9295 89 89 96 97 96 30° C. 87 73 86 97 85 80 86 72 88 94 84 84 40° C. 5539 76 77 48 41 55 42 70 79 49 40

TABLE 3 Savinase ® enzymatic activity as a percentage of initialenzymatic activity after 4 weeks of storage Storage DetergentComposition Temperature F1 F4* F2 F5* F3 F6* 25° C. 93 84 90 97 94 90 9282 89 100 92 97 30° C. 74 63 87 94 71 73 79 64 87 100 71 72 40° C. 37 2356 70 37 21 37 23 56 68 34 22

Results for Stainzyme® Plus are shown in Table 4 which shows enzymaticactivity data after 2 weeks of storage and Table 5 which shows enzymaticactivity data after 4 weeks of storage. Detergent compositions F4*-F6*maintained an amount of Stainzyme® Plus enzymatic activity suitable toclean and/or disinfect an object after 4 weeks of storage at 25 degreesCelsius, 30 degrees Celsius, and 40 degrees Celsius. Detergentcomposition F5* had an enhanced Stainzyme® Plus storage stabilitycompared to detergent composition F2 after 4 weeks of storage at 40degrees Celsius. Detergent composition F6* had an enhanced Stainzyme®Plus storage stability compared to detergent composition F3 after 4weeks of storage at 25 degrees Celsius, and 30 degrees Celsius, 40degrees Celsius.

TABLE 4 Stainzyme ® Plus enzymatic activity as a percentage of initialenzymatic activity at 2 weeks Storage Detergent Composition TemperatureF1 F4* F2 F5* F3 F6* 25° C. 90 98 98 85 96 100 89 97 95 89 96 100 30° C.85 96 91 87 94 100 84 97 93 84 94 100 40° C. 68 80 76 82 78 99 67 84 7880 76 97 50° C. 63 74 50 73 16 86 62 74 50 71 16 85

TABLE 5 Stainzyme ® Plus enzymatic activity as a percentage of initialenzymatic activity at 4 weeks Storage Detergent Composition TemperatureF1 F4* F2 F5* F3 F6* 25° C. 85 96 92 88 93 100 82 95 93 88 93 100 30° C.76 93 83 84 86 100 75 93 83 84 85 99 40° C. 48 67 58 71 14 81 49 65 6172 14 83 50° C. 47 60 40 61 14 72 47 60 38 61 14 72

Example 3

Detergent compositions A1-A4, provided below, were manufactured as shownin Table 6. Glycine and calcium chloride were obtained from VWRInternational, Randor, Pa. Sodium hydroxide was obtained fromSigma-Aldrich, St. Louis, Mo. Propylene glycol was obtained from Ward'sScience, Rochester, N.Y. Ethylene glycol was obtained from VWRInternational, Randor, Pa. Colatrope® OD was obtained from ColonialChemical, Inc., South Pittsburgh, Tenn., USA. Dehypon® LS 54, Dehypon®LS 36, Pluronic® L62, and Trilon M® were obtained from BASF SE,Ludwigshafen, Germany. Baypure® CX100 was obtained from Lanxess AG,Cologne, Germany. Dissolvine® GLS 47 was obtained from Akzo Nobel N.V.,Amsterdam, Netherlands.

1 kilogram of each detergent composition A1-A4 was prepared.

TABLE 6 Weight percentage (wt. %) of each component of the detergentcompositions A1-A4 based on the total weight of the compositionComponent Detergent Compositions Component Type A0 A1 A2 A3 A4De-ionized Solvent Qs to Qs to Qs to Qs to Qs to water 100 100 100 100100 Propylene Solvent 20 10 12 15 0 glycol Ethylene Solvent 0 0 0 0 15glycol Sodium Hydrotrope 0 10 0 0 12 xylene sulfonate Sodium Hydrotrope0 0 0 10 0 cumene sulfonate Colatrope ® Hydrotrope 15 0 15 0 0 ODCalcium Enzyme 0.05 0.03 0.1 0.2 0.05 chloride stabilizer Sodium Enzyme1 0.5 1.5 3 2 citrate stabilizer Sodium Chelating 1 2 0 0 0.7 gluconateagent Trilon ® M Chelating 0 0 1 0 0 agent Baypure ® Chelating 0 0 0 2 0CX100 agent Dissolvine ® Chelating 1 0 0 0 1.5 GLS 47 agent Dehypon ®Nonionic 3 5 0 0 4 LS 54 surfactant Dehypon ® Nonionic 0 0 2 0 1 LS 36surfactant Pluronic ® Nonionic 0 0 0 3 0.5 L62 surfactant Glycine pHbuffer 1.2 1 1.2 0.8 2 Amplify Amylase 3 1 2 10 8 100L enzyme Evens DUOProtease 5 1 1.5 7 15 100L enzyme Chloro- Antimicrobial 5 2 3 7 9hexidine agent (20% w/w solution in water) Sodium pH adjuster Up to Upto Up to Up to Up to hydroxide pH = pH = pH = pH = pH = 9 8 9 10 11 pH 98 9 10 11

Example 4

To determine the cleaning efficacy of detergent compositions of thepresent disclosure, formulation A0 according to the present disclosureand as described in Example 3, was compared to commercially availabledetergent compositions, C1-C6, which are not according to the presentdisclosure. Each detergent composition (A0 and C1-C6) was tested withand without addition of an antimicrobial agent to control for thepresence of an antimicrobial agent, which is not necessarily present inthe commercially available detergent compositions. For all detergentcompositions the antimicrobial agent was 5% by weight chlorhexidinegluconate (abbreviated as CHG), based on the total weight of thecomposition.

Detergent composition C1 is a commercially available neutral detergentcomposition comprising nonionic surfactants and triethanolamine.Detergent composition C2 is a commercially available enzymatic detergentcomposition comprising protease, amylase, and lipase enzymes. Detergentcomposition C3 is a commercially available enzymatic detergentcomposition comprising subtilisin protease. Detergent composition C4 isa commercially available detergent composition comprising anantimicrobial agent (a biguanide). Detergent composition C5 is acommercially available enzymatic detergent comprising subtilisins(protease enzyme). Detergent composition C6 is a commercially availabledual enzymatic detergent comprising proteinase subtilisin and subtilisin(protease enzyme).

Cleaning efficacy was tested using stainless steel and plastic coupons.The stainless steel coupons were Tosi® coupons available from HealthmarkIndustries Company, Inc., Fraser Mich., USA. Each Tosi® coupon comprisesa stainless steel plate treated with simulated blood test soil to createa surface appropriate to test for cleaning activity. The simulated bloodcomprises blood proteins in a sodium chloride and calcium chloridesolution. The plastic coupons were Verify® All Clean coupons availablefrom STEMS Corporation Mentor, Ohio, USA. Each Verify® All Clean couponcomprises a plastic plate treated with a test soil comprising proteins,lipids, and polysaccharides. Thus, testing was conducted for cleaning ofboth metal and plastic surfaces, with and without antimicrobial agent.

The following procedure was used to perform the cleaning tests. First,each detergent composition was diluted with 200 PPM hard water to therecommended concentration in a first beaker. For detergent compositionA0, the dilution factor was 1:100. Then, the resulting diluted detergentcomposition was heated to 45° C. Then, a plastic and stainless steelcoupon were immersed in the beaker for 10 min. After 10 min, each couponwas removed, and rinsed with de-ionized water. Then, each coupon wasdried at room temperature overnight and examined and photographed forcleaning efficacy.

Results are shown in FIGS. 2-8. Generally, each Figure has a panel A, B,C, and D, with one photograph in each panel. Panel A of each Figureshows a stainless steel coupon treated with a diluted detergentcomposition to which 5% CHG was added. Panel B of each Figure shows aplastic coupon treated with a diluted detergent composition to which 5%CHG was added. Panel C of each Figure shows a stainless steel coupontreated with a diluted detergent composition to which no CHG was added.Panel D of each Figure shows a plastic coupon treated with a diluteddetergent composition to which no CHG was added.

FIG. 2 shows photographs of stainless steel and plastic coupons thatwere treated with diluted detergent composition A0. Panel 2A shows astainless steel coupon treated with diluted detergent composition A0 towhich 5% CHG was added. Panel 2B shows a plastic coupon treated withdiluted detergent composition A0 to which 5% CHG was added. Panel 2Cshows a stainless steel coupon treated with diluted detergentcomposition A0 to which no CHG was added. Panel 2D shows a plasticcoupon treated with diluted detergent composition A0 to which no CHG wasadded.

FIG. 3 shows photographs of stainless steel and plastic coupons thatwere treated with diluted detergent composition C1. Panel 3A shows astainless steel coupon treated with diluted detergent composition C1 towhich 5% CHG was added. Panel 3B shows a plastic coupon treated withdiluted detergent composition C1 to which 5% CHG was added. Panel 3Cshows a stainless steel coupon treated with diluted detergentcomposition C1 to which no CHG was added. Panel 3D shows a plasticcoupon treated with diluted detergent composition C1 to which no CHG wasadded. For all panels A-D of FIG. 3, comparison to the correspondingpanels of FIG. 2 shows that cleaning efficacy is increased in detergentcompositions of the present disclosure, based on increased removal oftest soil in FIG. 2.

FIG. 4 shows photographs of stainless steel and plastic coupons thatwere treated with diluted detergent composition C2. Data for panels 4Aand B was not obtainable because the 5% CHG that was added to detergentcomposition C2 was insoluble. Panel 4C shows a stainless steel coupontreated with diluted detergent composition C2 to which no CHG was added.Panel 4D shows a plastic coupon treated with diluted detergentcomposition C2 to which no CHG was added. For panels C and D of FIG. 4,comparison to the corresponding panels of FIG. 2 shows that cleaningefficacy is increased in detergent compositions of the presentdisclosure, based on increased removal of test soil in FIG. 2.

FIG. 5 shows photographs of stainless steel and plastic coupons thatwere treated with diluted detergent composition C3. Data for panels 5Aand B was not obtainable because the 5% CHG that was added to detergentcomposition C3 was insoluble. Panel 5C shows a stainless steel coupontreated with diluted detergent composition C3 to which no CHG was added.Panel 5D shows a plastic coupon treated with diluted detergentcomposition C3 to which no CHG was added. For panels C and D of FIG. 5,comparison to the corresponding panels of FIG. 2 shows that cleaningefficacy is increased in detergent compositions of the presentdisclosure, based on increased removal of test soil in FIG. 2.

FIG. 6 shows photographs of stainless steel and plastic coupons thatwere treated with diluted detergent composition C4. Panel 6A shows astainless steel coupon treated with diluted detergent composition C4 towhich 5% CHG was added. Panel 6B shows a plastic coupon treated withdiluted detergent composition C4 to which 5% CHG was added. Panel 6Cshows a stainless steel coupon treated with diluted detergentcomposition C4 to which no CHG was added. Panel 6D shows a plasticcoupon treated with diluted detergent composition C4 to which no CHG wasadded. For all panels A-D of FIG. 6, comparison to the correspondingpanels of FIG. 2 shows that cleaning efficacy is increased in detergentcompositions of the present disclosure, based on increased removal oftest soil in FIG. 2.

FIG. 7 shows photographs of stainless steel and plastic coupons thatwere treated with diluted detergent composition C5. Panel 7A shows astainless steel coupon treated with diluted detergent composition C5 towhich 5% CHG was added. Panel 7B shows a plastic coupon treated withdiluted detergent composition C5 to which 5% CHG was added. Panel 7Cshows a stainless steel coupon treated with diluted detergentcomposition C5 to which no CHG was added. Panel 7D shows a plasticcoupon treated with diluted detergent composition C5 to which no CHG wasadded. For all panels A-D of FIG. 7, comparison to the correspondingpanels of FIG. 2 shows that cleaning efficacy is increased in detergentcompositions of the present disclosure, based on increased removal oftest soil in FIG. 2.

FIG. 8 shows photographs of stainless steel and plastic coupons thatwere treated with diluted detergent composition C6. Data for panels 8Aand B was not obtainable because the 5% CHG that was added to detergentcomposition C6 was insoluble. Panel 8C shows a stainless steel coupontreated with diluted detergent composition C6 to which no CHG was added.Panel 8D shows a plastic coupon treated with diluted detergentcomposition C6 to which no CHG was added. For panels C and D of FIG. 8,comparison to the corresponding panels of FIG. 2 shows that cleaningefficacy is increased in detergent compositions of the presentdisclosure, based on increased removal of test soil in FIG. 2.

Example 5

To determine the cleaning and disinfection efficacy of detergentcompositions of the present disclosure, formulation A0, according to thepresent disclosure and as described in Example 3, was compared tocommercially available detergent composition C2 which is not accordingto the present disclosure. Each detergent composition (A0 and C2) wastested for the ability to remove bacterial biofilms. This was measured,first, based on the ability of treatment with the detergent compositionto reduce bacterial presence and, second, based on the ability oftreatment with the detergent composition to reduce protein content ofthe biofilm.

Biofilms comprising Pseudomonas aeruginosa were grown in the lumen of atest object according to the ISO/TS 15883-5 Annex F method. 8 testobjects comprising P. aeruginosa biofilm were treated using an automatedendoscope reprocessor. The treatments were performed in an automatedendoscope repressor at 45° C. and at an exposure time of 8 min. In 4 ofthe treatments a test object was treated with diluted detergentcomposition AX, at a dilution factor of 1:100. In the other 4treatments, a test object was treated with diluted detergent compositionC2, at a dilution factor of 0.8:100, as recommended by the manufacturer.Subsequent to the treatment, test objects were analyzed for colonyforming units (CFUs) and for total protein utilizing a BCA proteinassay. These values were compared to those obtained for an untreatedtest object comprising the biofilm to determine fold-reduction ofbacteria and percent reduction of total protein.

Results for reduction of bacteria are displayed in Table 7. In Replicate1, treatment of a test object with diluted detergent composition A0resulted in a Log₁₀-fold reduction of bacteria of 6.98 (e.g., areduction of 10^(6.98)-fold). In Replicate 1, treatment of a test objectwith diluted detergent composition C2 resulted in a Log₁₀-fold reductionof bacteria of 2.64 (e.g., a reduction of 10^(2.64)-fold). In Replicate2, treatment of a test object with diluted detergent composition A0resulted in a Log₁₀-fold reduction of bacteria of 6.85 (e.g., areduction of 10^(6.85)-fold). In Replicate 2, treatment of a test objectwith diluted detergent composition C2 resulted in a Log₁₀-fold reductionof bacteria of 4.89 (e.g., a reduction of 10⁴⁻⁸⁹-fold). In Replicate 3,treatment of a test object with diluted detergent composition A0resulted in a Log₁₀-fold reduction of bacteria of 6.02 (e.g., areduction of 10^(6.02)-fold). In Replicate 3, treatment of a test objectwith diluted detergent composition C2 resulted in a Log₁₀-fold reductionof bacteria of 1.38 (e.g., a reduction of 10^(1.38)-fold). In Replicate4, treatment of a test object with diluted detergent composition A0resulted in a Log₁₀-fold reduction of bacteria of 6.22 (e.g., areduction of 10^(6.22)-fold). In Replicate 4, treatment of a test objectwith diluted detergent composition C2 resulted in a Log₁₀-fold reductionof bacteria of 3.56 (e.g., a reduction of 10^(3.56)-fold).

These results indicate that cleaning and disinfecting efficacy isincreased in detergent compositions of the present disclosure, based onthe increased removal of bacteria demonstrated by diluted detergentcomposition A0 in Table 7, compared to diluted detergent composition C2.

TABLE 7 Log₁₀-fold reduction of bacteria. Diluted detergent Diluteddetergent composition A0 (Log₁₀-fold composition C2 (Log₁₀-fold change)change) Replicate 1 6.98 2.64 Replicate 2 6.85 4.89 Replicate 3 6.021.38 Replicate 4 6.22 3.56

Results for reduction of total protein are displayed in Table 8. InReplicate 1, treatment of a test object with diluted detergentcomposition A0 resulted in a reduction of total protein on the testobject of 95.5%. In Replicate 1, treatment of a test object with diluteddetergent composition C2 resulted in a reduction of total protein on thetest object of 72.3%. In Replicate 2, treatment of a test object withdiluted detergent composition A0 resulted in a reduction of totalprotein on the test object of 99.2%. In Replicate 2, treatment of a testobject with diluted detergent composition C2 resulted in a reduction oftotal protein on the test object of 86.2%. In Replicate 3, treatment ofa test object with diluted detergent composition A0 resulted in areduction of total protein on the test object of 98.8%. In Replicate 3,treatment of a test object with diluted detergent composition C2resulted in a reduction of total protein on the test object of 95.8%. InReplicate 4, treatment of a test object with diluted detergentcomposition A0 resulted in a reduction of total protein on the testobject of 92.4%. In Replicate 4, treatment of a test object with diluteddetergent composition C2 resulted in a reduction of total protein on thetest object of 81.2%.

In each replicate shown in Table 8, cleaning and disinfecting efficacywas increased in detergent compositions of the present disclosure, basedon the increased removal of total protein demonstrated by diluteddetergent composition A0, compared to diluted detergent composition C2.

TABLE 8 Percent reduction of protein. Diluted detergent Diluteddetergent composition A0 composition C2 Replicate 1 95.5% 72.3%Replicate 2 99.2% 86.2% Replicate 3 98.8% 95.8% Replicate 4 92.4% 81.2%

The grammatical articles “a”, “an”, and “the”, as used herein, areintended to include “at least one” or “one or more”, unless otherwiseindicated, even if “at least one” or “one or more” is expressly used incertain instances. Thus, the articles are used herein to refer to one ormore than one (i.e., to “at least one”) of the grammatical objects ofthe article. Further, the use of a singular noun includes the plural,and the use of a plural noun includes the singular, unless the contextof the usage requires otherwise.

One skilled in the art will recognize that the herein describedcompositions, methods, and the discussion accompanying them are used asexamples for the sake of conceptual clarity and that variousconfiguration modifications are contemplated. Consequently, as usedherein, the specific exemplars set forth and the accompanying discussionare intended to be representative of their more general classes. Ingeneral, use of any specific exemplar is intended to be representativeof its class, and the non-inclusion of specific components (e.g.,operations), devices, and objects should not be taken limiting.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely exemplary, and that in fact many other architectures may beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “associated with” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected,” or“operably coupled,” to each other to achieve the desired functionality,and any two components capable of being so associated can also be viewedas being “operably couplable,” to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to physically mateable and/or physically interactingcomponents, and/or wirelessly interactable, and/or wirelesslyinteracting components, and/or logically interacting, and/or logicallyinteractable components.

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flows are presented in asequence(s), it should be understood that the various operations may beperformed in other orders than those which are illustrated, or may beperformed concurrently. Examples of such alternate orderings may includeoverlapping, interleaved, interrupted, reordered, incremental,preparatory, supplemental, simultaneous, reverse, or other variantorderings, unless context dictates otherwise. Furthermore, terms like“responsive to,” “related to,” or other past-tense adjectives aregenerally not intended to exclude such variants, unless context dictatesotherwise.

Although various examples have been described herein, manymodifications, variations, substitutions, changes, and equivalents tothose examples may be implemented and will occur to those skilled in theart. Also, where materials are disclosed for certain components, othermaterials may be used. It is therefore to be understood that theforegoing description and the appended claims are intended to cover allsuch modifications and variations as falling within the scope of thedisclosed examples. The following claims are intended to cover all suchmodification and variations.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

Various aspects of the invention according to the present disclosureinclude, but are not limited to, the aspects listed in the followingnumbered clauses.

-   -   1. A detergent composition comprising:        -   at least 0.001% by weight of an antimicrobial agent, based            on the total weight of the composition;        -   an enzyme; and        -   at least 0.01% a hydrotrope, based on the total weight of            the composition.    -   2. The composition of clause 1, wherein the hydrotrope comprises        an anionic hydrotrope.    -   3. The composition of clause 2, wherein the anionic hydrotrope        comprises at least one of an alkanoic acid, an aromatic sulfonic        acid, an aromatic carboxylic acid, and a salt of any thereof.    -   4. The composition of clause 3, wherein the aromatic sulfonic        acid is at least one of xylene sulfonic acid, cumene sulfonic        acid, and a salt of any thereof.    -   5. The composition of any one of clauses 1-4, comprising 0.1% or        less by weight of a boron-containing compound, based on the        total weight of the composition.    -   6. The composition of any one of clauses 1-5, comprising either        no boron-containing compound or only an incidental amount.    -   7. The composition of any one of clauses 1-6, wherein the        antimicrobial agent comprises at least one of a biguanide        compound and a quaternary ammonium compound.    -   8. The composition of clause 7, wherein the biguanide compound        comprises at least one of chlorhexidine and a salt thereof.    -   9. The composition of any one of clauses 1-8, wherein the enzyme        comprises at least one of a lipase, a protease, a peptidase, an        amylase, a glycosidase, a cellulase, DNAse and a nuclease.    -   10. The composition of any one of clauses 1-9, wherein the        composition has a pH in a range of 6 to 11.    -   11. The composition of any one of clauses 1-10, further        comprising at least one of        -   at least 0.0001% by weight of a buffer, based on the total            weight of the composition, and        -   at least 0.0001% by weight of a pH adjusting agent, based on            the total weight of the composition.    -   12. The composition of any one of clauses 1-11, further        comprising at least 0.01% by weight of a solvent, based on the        total weight of the composition.    -   13. The composition of clause 12, wherein the solvent comprises        at least one of a glycol ether, propylene glycol, ethylene        glycol, methanol, ethanol, isopropanol, and n-propanol.    -   14. The composition of any one of clauses 1-13, further        comprising at least one of a chelating agent and a salt.    -   15. The composition of any one of clauses 1-14, further        comprising at least 10% by weight of water, based on the total        weight of the composition.    -   16. The composition of any one of clauses 1-15, further        comprising at least 0.005% by weight of a non-ionic surfactant,        based on the total weight of the composition.    -   17. The composition of clause 16, wherein the non-ionic        surfactant is low foam.    -   18. A method of making a detergent composition, the method        comprising:        -   combining, based on the total weight of the composition,            -   at least 0.001% by weight of an antimicrobial agent,            -   at least 0.01% by weight of a hydrotrope; and            -   an enzyme.    -   19. The method of clause 18, further comprising adjusting a pH        of the detergent composition prior to the adding the enzyme.    -   20. The method of any one of clauses 18-19, further comprising        adding at least one of a buffer, a chelating agent, a solvent,        water, a non-ionic surfactant, and a salt.    -   21. A method for cleaning an object, comprising:        -   applying a detergent composition to the object, the            composition comprising, based on the total weight of the            composition:            -   at least 0.001% by weight of an antimicrobial agent,            -   at least 0.01% by weight of a hydrotrope, and            -   an enzyme        -   thereby cleaning the object.    -   22. The method of clause 21, wherein the object comprises an        endoscope.    -   23. The method of any one of clauses 21-22, further comprising        disinfecting the object.    -   24. The method of any one of clauses 21-23, wherein the applying        the composition comprises utilizing an automated endoscope        re-processor.    -   25. The method of any one of clauses 21-24, wherein an operating        temperature is from 15° C. to 60° C.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more examples has been presented for purposes of illustrationand description. It is not intended to be exhaustive or limiting to theprecise form disclosed. Modifications or variations are possible inlight of the above teachings. The one or more examples were chosen anddescribed in order to illustrate principles and practical application tothereby enable one of ordinary skill in the art to utilize the variousexamples and with various modifications as are suited to the particularuse contemplated. It is intended that the claims submitted herewithdefine the overall scope.

While the present disclosure provides descriptions of various specificaspects for the purpose of illustrating various aspects of the presentdisclosure and/or its potential applications, it is understood thatvariations and modifications will occur to those skilled in the art.Accordingly, the invention or inventions described herein should beunderstood to be at least as broad as they are claimed, and not as morenarrowly defined by particular illustrative aspects provided herein.

1-25. (canceled)
 26. A detergent composition, comprising: at least 1% byweight of an antimicrobial agent, based on the total weight of thedetergent composition; an enzyme; at least 1% by weight of a hydrotrope,based on the total weight of the detergent composition; and water,wherein the composition comprises 10% or less by weight of a non-ionicsurfactant, based on the total weight of the detergent composition. 27.The detergent composition of claim 26, wherein the hydrotrope comprisesat least one of an alkanoic acid, an aromatic sulfonic acid, an aromaticcarboxylic acid, and a salt of any thereof.
 28. The detergentcomposition of claim 26, wherein the antimicrobial agent comprises atleast one of a biguanide compound and a quaternary ammonium compound.29. The detergent composition of claim 28, wherein the biguanidecompound comprises at least one of chlorohexidine and a salt thereof.30. The detergent composition of claim 26, wherein the enzyme comprisesat least one of a lipase, a protease, a peptidase, an amylase, aglycosidase, a cellulase, DNAse, and a nuclease.
 31. The detergentcomposition of claim 26, wherein the composition has a pH in a range of6 to
 11. 32. The detergent composition of claim 26, further comprisingat least one of: at least 0.0001% by weight of a buffer, based on thetotal weight of the detergent composition; at least 0.0001% by weight ofa pH adjusting agent, based on the total weight of the detergentcomposition; at least 0.01% by weight of a solvent, based on the totalweight of the detergent composition; at least one of a chelating agentand a salt; at least 0.005% by weight of the non-ionic surfactant, basedon the total weight of the composition; and either no boron-containingcompound or only an incidental amount.
 33. The detergent composition ofclaim 26, further comprising at least 10% by weight of the water, basedon the total weight of the detergent composition.
 34. The detergentcomposition of claim 26, further comprising at least 5% by weight of thehydrotrope, based on the total weight of the detergent composition. 35.The detergent composition of claim 26, further comprising at least 2% byweight of the anti-microbial agent, based on the total weight of thedetergent composition.
 36. The detergent composition of claim 26,wherein the enzyme is present in the composition in an effective amountto remove and/or eliminate debris and/or bioburden.
 37. A dilutedcomposition formed by adding a diluent to the detergent composition ofclaim
 26. 38. The diluted composition of claim 37, wherein the diluentcomprises water.
 39. A method comprising forming a diluted compositionby adding a diluent to the detergent composition of claim
 26. 40. Themethod of claim 39, wherein the diluent comprises water.
 41. A detergentcomposition comprising: 0.1% to 20% by weight of a biguanide compound,based on the total weight of the detergent composition; an enzymepresent in the detergent composition in an effective amount to removeand/or eliminate debris and/or bioburden; 1% to 30% by weight of ahydrotrope, based on the total weight of the detergent composition; atleast 20% by weight of water, based on the total weight of the detergentcomposition; and 2% to 10% by weight of a non-ionic surfactant, based onthe total weight of the detergent composition.
 42. The composition ofclaim 41, wherein the hydrotrope comprises at least one of an alkanoicacid, an aromatic sulfonic acid, an aromatic carboxylic acid, and a saltof any thereof, wherein the biguanide compound comprises at least one ofchlorohexidine and a salt thereof, wherein the enzyme comprises at leastone of a lipase, a protease, a peptidase, an amylase, a glycosidase, acellulase, DNAse and a nuclease; and wherein the detergent compositionhas a pH in a range of 6 to
 11. 43. The detergent composition of claim41, further comprising at least one of: at least 0.0001% by weight of abuffer, based on the total weight of the detergent composition; at least0.0001% by weight of a pH adjusting agent, based on the total weight ofthe detergent composition; at least 0.01% by weight of a solvent, basedon the total weight of the detergent composition; and at least one of achelating agent and a salt.
 44. A diluted composition formed by adding adiluent to the detergent composition of claim
 41. 45. The dilutedcomposition of claim 44, wherein the diluent comprises water.
 46. Amethod comprising forming a diluted composition by adding a diluent tothe detergent composition of claim
 41. 47. The method of claim 46,wherein the diluent comprises water.